The Incidence of Postpartum Hepatitis in Pregnant Women With Chronic Hepatitis B Virus Infection

Not Applicable

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Tenofovir Disoproxil Fumarate

• Registration Number: NCT03214302
• Lead Sponsor: Beijing Ditan Hospital

Brief Summary

The majority of childbearing age women with hepatitis B virus infection were still in the immune tolerance period. Our recent research had shown that most puerperae after delivery had elevated ALT level. However, there is no withdrawal time recommendations after childbirth at present.Through the study of hepatitis occurrence after delivery and drug withdrawal, the investigators explore the withdrawal time of antiviral treatment during pregnancy.

Detailed Description

Most of childbearing age women with hepatitis B virus infection were still in the immune tolerance period. Our recent research had shown that most puerperae after delivery had elevated ALT level, and 11.5% of patients with HBV DNA positive would lead to deterioration of liver function. Meanwhile, the highest peak of ALT level could occur in 2 weeks after delivery, then it would dropped to a low point in 4-5 weeks. However, there is no withdrawal time recommendations after childbirth at present.The aim of our study is to investigate the changes of serological indexes, the changing rule of the liver function, hepatitis status, and its correlation with antiviral therapy in pregnant women with HBV infection after delivery, and then explore the withdrawal time of antiviral treatment during pregnancy.

Study Timeline

• Study Start: 2017-01-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-11
• Last Update Submitted: 2017-07-11
• Last Update Posted: 2017-07-13
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 560

Inclusion Criteria

• Pregnant women who were chronic hepatitis B and had achieved HBeAg positive and HBV DNA > 106 copies/ml
• healthy Pregnant women with HBsAg(-), HBeAg(-)

Exclusion Criteria

• Active consumption of alcohol and/or drugs
• Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus, HIV, etc.
• History of autoimmune hepatitis
• Psychiatric disease
• Evidence of neoplastic diseases of the liver
• without gestational hypertension, premature rupture of membranes, antepartum haemorrhage diseases or amniotic fluid piercing history during pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	Tenofovir Disoproxil Fumarate	pregnant women with HBsAg/HBeAg positive and HBV DNA \> 106 copies/ml start to use Tenofovir Disoproxil Fumarate(TDF) antiviral treatment from the 32 weeks of gestation and drug withdrawal after delivery immediately, and drug withdrawal in the 6 weeks after delivery.

Primary Outcome Measures

Name	Time	Method
The incidence rate of hepatitis flare after drug withdrawal in maternal postpartum	after delivery 24weeks	ALT \> 3 times the upper limit of normal

Trial Locations

Locations (1)

Beijing Ditan hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China